ADITEC Call for EC Funded Commissioned Research Support for Vaccine Development Deadline: 13 November 2015 5:00 p.m. CET Anticipated Decision Date 15 February 2016 The High Impact project on Advanced Immunization Technologies (ADITEC), funded through the 7th Framework Programme of the European Union, aims to accelerate the development of novel and powerful immunization technologies for the next generation of human vaccines. ADITEC is coordinated by the Sclavo Vaccines Association (SVA): a non-profit organization that strives to ensure long-term sustainability of European vaccine R&D efforts. ADITEC constitutes an important cornerstone of an expanded vaccine research partnership, geared to boost European research in the field of immunology and vaccinology. It is within this context that ADITEC will give interested vaccine R&D users free access to consortium "in house" available vaccinology expertise and technologies. By facilitating better coordination among European organizations involved in vaccine research, ADITEC hopes to expand European industry capacity in terms of vaccine R&D and production, thus promoting competitiveness of European health industries and significantly impacting population health in the future. Commissioned research for European Small and Medium size Enterprises (SME) and Public Health Organizations. The ADITEC project is looking to support SMEs and public health organizations from within or outside the ADITEC consortium in vaccine development work that will result in public health benefit. We are actively seeking research proposals clearly aimed at vaccine development, where specific support can be requested in the areas listed below. These services are offered by current ADITEC consortium partners and are available free of charge to the requesting SME or public health organization, upon approval of the proposal. A total of 1,299,878 Euros from ADITEC funding was allocated and up to 100 k€ may requested per project. The ADITEC project will reimburse the service-providing ADITEC partners directly; no funds will be distributed to the SME or public health organization requesting and receiving the service. There will be no cost to the awarded SME or public health organization for the service provided. Resulting IP will be owned by the SME or public health organization receiving the service, and maybe shared with the ADITEC partner(s) performing the research. It will be expected that results of the "commissioned research work" will be made available to European users, and the ADITEC support will be acknowledged. Successful external applicants, if wished so, may apply to become an ADITEC "Affiliated Member" including all respective rights as described in the Affiliated Member Application found on the ADITEC website. http://www.aditecproject.eu/aboutaditec/affiliated-members.html General Application Information For questions regarding any aspect of the submission process, please contact the ADITEC Project Manager Lynn Zimmerman zimmerman@sclavo.org Eligible Organizations: European SMEs and Public Health Organizations The applicant performs the majority of its work in an institution established in a European Member State or Associated State Is an small or medium-sized enterprise (SME, an enterprise which employs fewer than 250 persons and has an annual turnover not exceeding 50 million euro, and/or an annual balance sheet total not exceeding 43 million euro. For additional information on the definition of an SME, please see http://ec.europa.eu/enterprise/policies/sme/factsfigures-analysis/sme-definition/index_en.htm) Is a Public Health Organization. Able to commercialize or openly disseminate the results. Applicants may submit more than one application, provided each application is scientifically distinct. Supplemental travel and accommodation costs may be covered if the grantee is not in a position cover these costs. In these cases, costs are only reimbursed after the expenses have been incurred and upon submission of the requested reports and documentation. Costs must be consistent with ADITEC reimbursement guidelines and travel dates and estimated costs must be preapproved by ADITEC management. Estimated budget must be submitted with application. Application Process This form must be completed with any sections not applicable marked as such. All applications must be completed in English and are not to exceed four pages in length including attachments. Any attachments to your proposal must be submitted in PDF format, filenames must be included in the body of the proposal, and a pdf extension must be used. Applications must be emailed, with the “organization’s name and Commissioned Research Call”, in the subject line of the email. Your application will be acknowledged within 72 hours of receiving your application. Applications must be successfully received by Lynn Zimmerman (zimmerman@sclavo.org) and Laura Pacciarini (pacciarini@sclavo.org) no later than 5:00 p.m. CET on 13 Nov 2015. Under no circumstances will the Management Team accept responsibility for lost emails or consider applications received after the deadline. Applicants are totally responsible for ensuring that their applications are received and acknowledged within the deadline. In its commitment to adhere to the principles of transparency, fairness and impartiality, a committee of ADITEC partners other than those offering R&D services under the call, will be assembled to review applications both in light of impact relevance for SMEs and public health, consistency with ADITEC programme goals and scientific excellence. In addition, ADITEC's external advisory group will provide their recommendation on the projects to be chosen. All applicants will be notified via email of the results of their application upon completion of the selection process. Other Information Each recipient entering a support agreement will declare its commitment to deliver the reports and necessary documentation in a Letter of Acceptance which will be issued to the User upon positive evaluation of their proposal. The following items are mandatory and each recipient accessing the ADITEC support services commits to complying with the following requirements: All reporting content and timeline requirements. This will include, but may not be limited to the submission of organizational information to ADITEC or to the EC, a final report after awarded services are complete, a summary report when the full project is complete and EC required impact survey. Failure to provide any report may result in the awardee being billed for the entire cost of providing the services. The purpose of the report is to highlight the scientific output of the services received and shall be included in the ADITEC reports to the EC. The reports may be published on the ADITEC web site, be highlighted in the ADITEC newsletter or other ADITEC publications. Report templates will be created and distributed at a later date. An acknowledgement of the ADITEC project must be included in any such publications, exact wording to be distributed at a later time. All Applicants will send full citations and full text PDF copies of all publications resulting from or involving the work carried out under this award to the ADITEC management team. Any subsequent publications or patents created through the support of the EC funded ADITEC project must be communicated to the ADITEC management team. The providers for the animal and human models will collect and submit the necessary documentations to ethical committees and regulatory approvals. If a proposal fails to pass the ethical review the animal study cannot be performed and has no obligation to provide the services. To apply, please complete the following application form: Commissioned Research Support for Vaccine Development Principle Investigator Name Title Tel.: Mobile: Fax: E-mail: Name of Organization Mailing Address Country: Research Project Project Title Project Acronym (max 20 characters) Project Summary Total Budget Requested In most cases, initial discussions will need to occur with service provider to estimate budget request Requested Access to Service (Please check) Please be aware that all research support offered here must be applied for specifically as needed in the context of vaccine development. For specific questions regarding the individual services, please contact the providers directly Adjuvants Evaluation of potency of new exploratory adjuvants bench-marked against the established adjuvants systemically and/or mucosally as pertain to immune-profiling and functionality of the immune response in mice. University of Gothenburg, A. Harandi (ali.harandi@microbio.gu.se) 21,500€/adjuvant/1 full experiment with control and bench-mark arms. Pre-clinical QS-21 is available for use in their early vaccine formulations and GMP quality QS-21 for human clinical trials. Desert King International (ADITEC affiliated partner), D. Hiley (dfhiley@desertking.com). Three independent adjuvants: sodium arsenite, gramacidine and dithiocarbonate and high throughput template to analyse sequentially molecular interactions between any other adjuvant and dendritic T and B cells with particular reference to the inflammasome and homeostatic pathways leading to immunological memory. King’s College of London, T. Lehner (thomas.lehner@kcl.ac.uk). Animal models Mouse Model: University of Siena, D Medaglini (Medaglini@unisi.it) Perform pre-clinical studies in the mouse model to assess the immunogenicity of vaccine formulations and prime-boost strategies. Chlamydia Challenge Mouse Model: Statens Serum Institut, Frank Follmann (FRF@ssi.dk) Perform immunogenicity analysis and challenge experiment in the Chlamydia mouse model. Immunogenicity + Challenge of a group of 12 mice. The prize includes control groups (negative / positive). 12.000€ / vaccine group (of 10 mice) up to 4 groups TB Challenge Mouse Model: Statens Serum Institut, Else Marie Agger (EAG@ssi.dk) Perform immunogenicity analysis and challenge experiment in the TB mouse model. Immunogenicity + Challenge of a group of 10 mice. The prize includes control groups (negative / positive). 10.000€ / vaccine group (of 10 mice) up to 4 goups Influenza Challenge Mouse Model: Imperial College London, J Tregoning (john.tregoning@imperial.ac.uk) Perform influenza challenge models following immunisation. Immunisation can be by various routes, both mucosal and systemic. Infection can be with H1N1, H3N2 or B strains, enabling homologous or heterologous infection and protection assessed by disease and viral load measurements. Assess immunogenicity in the same animals – both antibody and cellular. N=5 mice per group, max 6 groups per study. Animal model to assess vaccination induced cellular immune responses and immune modulation: University Utrecht Willem van Eden (w.vaneden@uu.nl) Perform pre-clinical studies to test vaccination induced cellular responses and immunomodulatory activity of peptides and proteins, delivered via the intradermal route.. Groups of 10 animals with full cellular immunological monitoring following dermal vaccination. 8000€ per group Human Trials Human Challenge Models for Typhoid and parathyphoid vaccination/infection University of Oxford, A. Pollard (andrew.pollard@paediatrics.ox.ac.uk). Human Trials (including infants) for systems immunology to study transcriptome, B/T cell immunology University of Oxford, A. Pollard (andrew.pollard@paediatrics.ox.ac.uk). Clinical trial support from concept through to completion. Services can include: protocol design and review, regulatory submissions and approvals, sponsorship of clinical trials, project management of trial, pharmacovigilance and monitoring support, clinical trial delivery ,laboratory processing of samples, data management, statistical analysis and clinical study reporting. Surrey Clinical Research Centre, D. Lewis (D.J.Lewis@surrey.ac.uk) MLPA Assay Reverse Transcription Multiplex Ligation-dependent Probe Amplification is high throughput assay, which can rapidly profile mRNA expression of host. Leiden University Medical Center, T.Ottenhoff (T.H.M.Ottenhoff@lumc.nl) Multiplex detection of cytokine and chemokine biomarkers: evaluate the production of cell signaling proteins, such as cytokines, chemokines, and inflammatory biomarkers in multiple samples, using the Bio-Plex suspension array system University of Siena, A Ciabattini (annalisa.ciabattini@unisi.it) Formulation of vaccine antigens onto biodegradable particles: Formulate sub-unit or vaccine components onto biodegradable particles, containing or not in their core, different immunemodulators, such as TLR or Nod ligands, by using passive adsorption process onto Poly Lactic Acid (PLA) particles of 150<x<200nm size. CNRS, B Verrier. (bernard.verrier@ibcp.fr) Systems biology analysis and mathematical modeling: Construction, simulation and identification of stochastic and deterministic dynamical mathematical models of adaptive immune response in animal models. Statistical analysis of experimental data (probability distribution function estimation, classification, etc.). Interference of gene regulation networks. Università di Siena – Dipartimento di Ingegneria dell’Informazione e Scienze Matematiche, A Vicino (vicino@ing.unisi.it) Description of laboratory Please describe your laboratory and its associated facilities in relation to this request Relevant Publications Please list here your publications (with d.o.i) relevant to your application maximum 5 – 1. 2. 3. 4. 5. ADITEC Project: Sclavo Vaccines Association Siena Italy Email: info@sclavo.org http://www.aditecproject.eu/home.html